Clinical Study to Evauate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337; Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2; Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,

Study type: Interventional

Funder types: Industry

Identifiers

NCT04304547

A86_04BE1913P

Details and patient eligibility

About

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers

Enrollment: 15 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 19 ≤ age ≤ 45
2. Health Volunteers
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion criteria

1. Subject who cannot participate in a clinical trial based on the PI's judgment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Sequence A

Active Comparator group

Description:

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Treatment:

Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Sequence B

Active Comparator group

Description:

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Treatment:

Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,

Sequence C

Active Comparator group

Description:

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Treatment:

Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337